Model Number DM3500 |
Device Problem
Pacemaker Found in Back-Up Mode (1440)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/23/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Event Description
|
It was reported that the mobile application had missing device alert checks since (b)(6) 2019.Upon review, the insertable cardiac monitor reset had occurred and that monitoring was disabled.The patient would follow up for the device interrogation.No patient symptoms were reported.
|
|
Manufacturer Narrative
|
Device was returned.Analysis of the device image indicated that memory corruption occurred and triggered the alert message.Further testing was performed by reloading the product code and all tests results were normal, memory corruption could not be reproduced.The reset error noted is consistent with that occurred due to discrepant ic.
|
|
Event Description
|
New information received noted that the patient presented for a device interrogation.Upon review, the device was unable to be interrogated.The device was explanted and replaced on (b)(6) 2019.The patient was stable after the procedure.
|
|
Search Alerts/Recalls
|